MarketVue® Report
Celiac Disease (U.S.), 2022

Syndicated market assessment report driven by primary market research

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Celiac Disease (U.S.), October 2022

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The MarketVue®: Celiac Disease market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
 
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
 
Topics covered in this report:
  • Disease overview: Review the disease pathophysiology and potential druggable targets
  • Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
  • Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
  • Unmet needs: Identify opportunities to address treatment or disease management gaps
  • Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
  • Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
 
Methodology:
Research for the MarketVue®: Celiac Disease report is supported by 4 qualitative interviews with key opinion leaders (U.S. Gastroenterologists), a quantitative survey with 20 U.S. physicians and secondary research.
 
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
 
Key companies mentioned:
  • Takeda Pharmaceuticals
  • Anokion
  • GlaxoSmithKline
  • Immunic Therapeutics
  • Provention Bio
  • Amgen
  • Calypso Biotech
  • ImmunogenX
  • Chugai Pharmaceutical
 
Key drugs mentioned:
  • Budesonide
  • Azathioprine
  • TAK-101
  • KAN-101
  • TAK-1227
  • GSK3915393
  • Vidofludimus calcium / IMU-838
  • PRV-015
  • CALY-002
  • Latiglutenase
  • TAK-062
  • ZED1227
1. DISEASE OVERVIEW
A life-altering autoimmune disease in genetically pre-disposed individuals
Figure 1.1. Symptomatic presentations of CeD
Figure 1.2. Villous atrophy in CeD
Gluten digestion and the ensuing immune response offer numerous targets for drug development
Figure 1.3. Gluten activation of the immune system and druggable targets
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. G6 diagnosed prevalent cases of CeD by region
Table 2.1. Diagnosed prevalent and drug-treated CeD patients in the G6
The CeD patient population is segmented into three distinct sub-populations
Overview
Table 2.2. Description of CeD patient segments
Figure 2.2. Representation of CeD patient population segments
3. DIAGNOSIS AND CURRENT TREATMENT
Diagnosis overview
Figure 3.1. Diagnostic pathway for CeD patients
A gluten-free diet is the current standard of care for CeD
Figure 3.2. Treatment goals for CeD
Figure 3.3. Treatment rate among CeD patients
Figure 3.4. Budesonide and azathioprine patient share in NRCD patients
Treatment flow for CeD
Figure 3.5. Treatment algorithm for CeD
CeD diagnosis and treatment dynamics
Figure 3.6 Gastroenterologist statement agreement on CeD diagnosis and treatment dynamics
There is room for improvement over existing treatments
Table 3.1. Upsides and downsides of current CeD treatments
Key dynamics that shape treatment and disease management in CeD
Table 3.2 Must-know CeD treatment dynamics
The CeD market is poised to solidify with the first drug approval as early as 2025/2026
Figure 3.7. Important dynamics of CeD market evolution
4. UNMET NEED
Treatment-related unmet needs
Figure 4.1. Top unmet needs in CeD
Figure 4.2. Physician-reported unmet needs in CeD
Physician commentary on unmet needs for novel CeD therapies
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Number of emerging therapies whose primary clinical trial endpoint addresses unmet needs in CeD
The pipeline for CeD is active with numerous treatments in Phase 2 clinical development
Figure 5.2. Percentage of gastroenterologists rating emerging approaches as “promising”
Table 5.1. Emerging clinical-stage therapies by target
Gastroenterologists’ perspectives on emerging therapies
The pipeline for CeD is active with numerous treatments in phase 2 clinical development
6. VALUE & ACCESS
Overview
Figure 6.1. Reimbursement and access considerations for emerging therapies in CeD
Figure 6.2. CeD patients by insurance type
Key insights from the alopecia market
Table 6.2. Payer coverage requirements of Olumiant to treat alopecia and relevance to CeD
Improving patient access to new CeD medications will require strategic trial design and patient services
Figure 6.3. Key considerations for driving access to and uptake of novel CeD therapies
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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